Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods (Temp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220101
Recruitment Status : Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF

Brief Summary:
Comparison of four methods for measuring temperature perioperatively in patients scheduled for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme; Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner. The study is a single-center, observational study carried out by the Central Surgical and Intensive Section at Vestfold Hospital Trust.

Condition or disease
Hypothermia Hyperthermia

Detailed Description:

Issues

  • Perioperative hypothermia is associated with several serious complications and therefore most likely to be avoided. Monitoring of body temperature is therefore required perioperatively .
  • There are in the literature concerns that some methods of measuring temperature perioperatively is accurate enough and whether they reflect core temperature adequate.
  • Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) - measurements are accurate enough to measure the actual core temperature. Much of the research on TS measurements have been done on children and newborns in an intensive setting, but little perioperatively .

A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied Regional Ethics Committee. Patients will not get different treatment than standard treatment in hospital and it causes no follow-up calls or hospital visits. All patients (if possible) give written consent for participation.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia




Primary Outcome Measures :
  1. Temperature difference measured with different measuring methods [ Time Frame: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute) ]
    The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.


Secondary Outcome Measures :
  1. Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability. [ Time Frame: Hospital discharge ]
    An average of 10 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Laparoscopic surgery and in ICU patients
Criteria

Inclusion Criteria:

Surgical Patient group:

  • > 18 years
  • ASA 1-3
  • Laparoscopic surgery
  • Elective surgery

Intensive Patient group:

  • > 18 years
  • Defined as intensive patient
  • ASA 1-5

Exclusion Criteria:

Surgical Patient group:

  • BMI> 30 kg/m2
  • No bladder (ileum-bladder)
  • Known malignant hyperthermia
  • Malformations of the face that prevents nasopharynx and temporal scanner measurements
  • Patient is participating in another study that may influence the results of the Tempstudy
  • The patient is not competent to give consent, eg severe dementia
  • The patient INR> 2.0 and / or Trc <50

Intensive Patient group:

  • BMI> 30 kg/m2
  • No bladder (ileum-bladder)
  • Malformations of the face that prevents nasopharynx and temporal scanner measurements
  • Hypothermic patient below 32 ° C (bladder temperature)
  • Hyperterm patient over 40 ° C (bladder temperature)
  • Active cooling of the bladder
  • The patient is under ongoing cooling or heating
  • Patient is participating in another study that may influence the results of the Tempstudy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220101


Locations
Layout table for location information
Norway
Vestfold Hospital Trust
Tønsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
3M
Investigators
Layout table for investigator information
Study Director: Espen Lindholm, M.D. Departement of Anesthesiology, Vestfold Hospital Trust
Layout table for additonal information
Responsible Party: Espen Lindholm, Chief of Department of Anesthesiology section, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02220101    
Other Study ID Numbers: 1A
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Espen Lindholm, Sykehuset i Vestfold HF:
hypothermia
core temperature
temperature measurement methods
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypothermia
Fever
Body Temperature Changes